Comparison of drug-eluting bead with conventional transcatheter arterial chemoembolization for hepatocellular carcinoma with portal vein tumor thrombus: a randomized clinical trial

Abstract

Background: Drug-eluting bead transarterial chemoembolization (DEB-TACE) has shown efficacy for treating hepatocellular carcinoma (HCC) with portal vein tumor thrombus (PVTT). However, whether DEB-TACE is superior to conventional TACE (cTACE) remains unclear.

Objective: This randomized controlled trial aimed to compare the efficacy and safety of DEB-TACE versus cTACE in treating HCC with PVTT.

Methods: The study was conducted at a tertiary care center in Southeast China. HCC patients with PVTT were randomized at a 1:1 ratio into the DEB-TACE or cTACE groups. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were overall survival (OS) and the incidence of adverse events (AEs). An independent review committee assessed the radiologic response according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST). AEs were assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Systemic therapies were not restricted.

Results: Between September 2018 and July 2020, 163 patients were randomized to undergo DEB-TACE ( n =82) or cTACE ( n =81). Nine patients were excluded, and 154 patients were included in the final analysis; the median age was 55 years (range, 24-78 years), and 140 (90.9%) were male. The median PFS in the DEB-TACE group was 6.0 months (95% CI, 5.0-10.0) versus 4.0 months (95% CI, 3.0-5.0) in the cTACE group (hazard ratio, 0.63; 95% CI, 0.42-0.95; P =0.027). The DEB-TACE group showed a higher response rate [51 (66.2%) vs. 36 (46.8%); P =0.0015] and a longer median OS [12.0 months (95% CI, 9.0-16.0) vs. 8.0 months (95% CI, 7.0-11.0), P =0.039] than the cTACE group. Multivariate analysis showed that the treatment group, ALBI score, distant metastasis and additional TKIs were the four independent prognostic factors correlated with PFS. In addition, the treatment group, PVTT group and combination with surgery were independently associated with OS. AEs were similar in the two groups, and postembolization syndrome was the most frequent AE.

Conclusion: DEB-TACE is superior to cTACE in treating HCC patients with PVTT, demonstrating improved PFS and OS with an acceptable safety profile, and may thus emerge as a promising treatment strategy for HCC patients with PVTT.

Trial registration: Chinese Clinical Trial Registry ChiCTR1800018035.

Graphical abstract

Figure 1

Summary flow chart of the study. cTACE, conventional transarterial chemoembolization; DEB-TACE, drug-eluting bead TACE; ECOG, Eastern Cooperative Oncology Group;

Figure 2

A typical case of DEB-TACE treating hepatocellular carcinoma (HCC) with PVTT. (A) Contrast-enhanced portal venous phase CT scan in the axial plane shows the infiltrative HCC in the S6 hepatic segment with PVTT in the right branch of the portal vein and the main portal vein (type Ⅲ). (B) DSA of the common hepatic artery shows a large irregular tumor stain in segment 6 and streaklike tumor blood vessels (yellow arrow) in PVTT. (C) DSA after DEB-TACE shows tumor and PVTT staining disappeared. (D) Enhanced CT images in the portal venous phase indicate complete necrosis of both the tumor and the PVTT one month after D-TACE treatment. CT, computed tomography; DEB-TACE, drug-eluting bead transarterial chemoembolization; PVTT, portal vein tumor thrombus.

Figure 3

Kaplan–Meier plots of median PFS and OS in the ITT (A, B) and PP (C, D) population. Efficacy outcomes in participants in the drug-eluting bead transarterial chemoembolization group versus cTACE group for the treatment of hepatocellular carcinoma with portal vein tumor thrombus. Kaplan–Meier plots show PFS and OS in the ITT population (A, B) and the PP population (C, D). Note: P values were calculated by using the log-rank test. Dashed lines indicate 95% CIs. cTACE, conventional transarterial chemoembolization; HR, hazard ratio; ITT, intent-to-treat; OS, overall survival; PFS, progression-free survival; PP, per-protocol.